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Manual AVE733

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0% found this document useful (0 votes)
530 views64 pages

Manual AVE733

Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

AVE-73 Series Urine Analyzer

User’s Manual

AVE SCIENCE & TECHNOLOGY CO., LTD.

Building B6, Luguyuyuan, No.27 Wenxuan Road, Changsha Hi-tech Industrial Development Zone, Changsha,
The information in this manual was correct at the time of printing.
Hunan 410205, [Link]
AVE-73 Urine Analyzer User's Manual
However, AVE SCIENCE & TECHNOLOGY continues to improve its products and
reserves the right to change specifications, equipment, and maintenance procedures at
any time without notice.
Companies, names and data used in examples are fictitious unless otherwise noted. No
part of this document may be reproduced or transmitted in any form or by any means,
electronic, mechanical or otherwise, for any purpose, without the express written
permission of AVE. AVE may have patents or pending patent applications, trademarks,
copyrights or other intellectual or industrial property rights covering this document or
subject matter in this document. The furnishing of this document does not give a license to
these property rights except as expressly provided in any written license agreement from
AVE.

If this instrument is used in a manner differently than specified in this manual, the
protection provided by the equipment may be impaired.

Modification history
Version Date Modification

1.0 31.1.2021 First edition

INDEX
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AVE-73 Urine Analyzer User's Manual
1 PREFACE ....................................................... 1

1.1 Application Scope ............................................................................................................. 1

1.2 Product Classification ...................................................................................................... 1

1.3 How to Use User Manual ................................................................................................ 1

1.4 Precaution Measures and Warning Symbols—Definitions ................................. 2

1.4.1 Cautions .................................................................................................................... 2

1.4.2 Warnings ................................................................................................................... 2

1.4.3 Biohazard Warning................................................................................................ 2

1.5 Symbols ................................................................................................................................ 3

1.6 Contact Information ......................................................................................................... 4

1.7 Statement ............................................................................................................................. 5

1.8 Warranty ............................................................................................................................... 7

1.9 Limitation of Liability........................................................................................................ 8

1.10 Safety Instructions and Precautions ......................................................................... 8

1.11 Intellectual Property....................................................................................................... 8

2 SYSTEM INSTRUCTION ......................................... 10

2.1 Working Principle ............................................................................................................ 10

2.2 Performance and Technical Indicators .................................................................... 11

2.2.1 Main Detected Parameters ............................................................................... 11

2.2.2 Main Functions ..................................................................................................... 11

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AVE-73 Urine Analyzer User's Manual

2.2.3 Perfomance Indicators ....................................................................................... 12

[Link] Testing Speed ............................................................................................ 12

[Link] Repeatability .............................................................................................. 13

[Link] Accuracy ...................................................................................................... 13

[Link] Stability ........................................................................................................ 13

[Link] Carryover Contamination...................................................................... 13

2.3 System Structures............................................................................................................ 14

2.3.1 AVE-733A Urine Analyzer Host ....................................................................... 14

2.3.2 Data Analysis Processor .................................................................................... 15

2.4 Software Function and Composition........................................................................ 16

2.4.1 Test Menu ............................................................................................................... 18

2.4.2 Inquiry Menu......................................................................................................... 19

2.4.3 Setting Menu......................................................................................................... 20

3 INSTALLATION ................................................. 22

3.1 Summary ............................................................................................................................ 22

3.2 Installation Requirements ............................................................................................ 22

3.2.1 Space ........................................................................................................................ 22

3.2.2 Power ....................................................................................................................... 22

3.2.3 Environmental requirements ........................................................................... 23

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AVE-73 Urine Analyzer User's Manual

3.2.4 Installation requirement .................................................................................... 24

3.3 Packing list ......................................................................................................................... 24

3.4 Load Paper into Printer ................................................................................................. 25

3.5 Power cord connection ................................................................................................. 26

4 SETTINGS ..................................................... 27

4.1 Instrument settings......................................................................................................... 28

4.1.1 Parameter settings .............................................................................................. 28

4.1.2 Factory information ............................................................................................ 29

4.1.3 Software upgrade ................................................................................................ 30

4.2 Quality control settings ................................................................................................. 30

4.3 Report setting ................................................................................................................... 32

5 SAMPLE PROCESSING ......................................... 34

5.1 Power on ............................................................................................................................ 34

5.2 Sample Preparation ........................................................................................................ 34

5.2.1 Ambient temperature requirements ............................................................. 35

5.3 Urine chemistry strips preparation ........................................................................... 35

5.4 Sample test ........................................................................................................................ 36

5.5 Quality Control ................................................................................................................. 41

5.5.1 Control Frequency ............................................................................................... 41

5.5.2 QC Parameters Input .......................................................................................... 41

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AVE-73 Urine Analyzer User's Manual

5.5.3 Running QC ........................................................................................................... 41

5.5.4 QC result ................................................................................................................. 42

[Link] QC test result ............................................................................................. 42

[Link] QC Inquiry .................................................................................................. 42

5.5.5 Remedies on Out-of-control ............................................................................ 44

5.6 Data inquiry ....................................................................................................................... 44

5.6.1 Patient data entry ................................................................................................ 44

5.6.2 Print report ............................................................................................................ 45

5.6.3 Data inquiry ........................................................................................................... 45

5.7 Power off ............................................................................................................................ 47

6 MAINTENANCE AND SERVICE ................................... 50

6.1 Maintenance ..................................................................................................................... 50

6.1.1 Precautions ............................................................................................................ 50

6.1.2 Daily Maintenance............................................................................................... 50

6.1.3 Periodic Maintenance......................................................................................... 51

6.2 Daily Maintenance .......................................................................................................... 51

6.2.1 Cleaning Instrument Surface ........................................................................... 51

6.2.2 Cleaning Waste Strip Box .................................................................................. 51

6.3 Weekly Maintenance ...................................................................................................... 53

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AVE-73 Urine Analyzer User's Manual

6.3.1 Cleaning strip tray ............................................................................................... 53

6.4 As Needed Maintenance .............................................................................................. 54

6.4.1 Cleaning Photoelectric Sensors ...................................................................... 54

6.4.2 Changing the Fuse .............................................................................................. 54

6.5 Troubleshooting .............................................................................................................. 55

VII
AVE-73 Urine Analyzer User's Manual

1 PREFACE

1.1 Application Scope

Used, with matched urine test strips, for semi-quantitative analysis of clinical

urine routine parameters by medical institutions.

1.2 Product Classification

AVE-73 series urine analyzers, based on Medical Devices Management

Category, belong to clinical detection and analysis analyzer and are Class II medical

devices.

Over-voltage category applied: Class II, pollution level: Class 2.

1.3 How to Use User Manual

AVE-73 series urine analyzers’eight models (including AVE-731A urine

analyzer, AVE-731B urine analyzer, AVE-731C urine analyzer, AVE-731D urine

analyzer, AVE-732A urine analyzer, AVE-732B urine analyzer, AVE-733A urine

analyzer and AVE-733B urine analyzer, hereafter called AVE-73 series urine

analyzers) only have the diffirence of product software control module. The

principles and the hardware structures are all the same. Therefore, this manual is

use AVE-733A urine analyzer as the reference to edit using instructions, completely

introduce performance and operation methods, it also can be used as training

instruction and trouble shooting by operator. Before using AVE-73 series urine

analyzer, please carefully read and understand its content to make sure use AVE-73

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AVE-73 Urine Analyzer User's Manual

series urine analyzer correctly, realize the best performace and gurantee the safety

of operator.

1.4 Precaution Measures and Warning

Symbols—Definitions

The manual include informations and warnings to which operator must pay

attention in order to make sure safe operation of software.

1.4.1 Cautions

CAUTION: Identifies situation that could lead to an accident or

equipment failure.

CAUTION: Identifies electrical caution! Unplug before handling.

1.4.2 Warnings

WARNING: Identifies potentially hazardous situation that could result

in serious injury to laboratory personnel.

1.4.3 Biohazard Warning

BIOHAZARD WARNING: Identifies potential biohazard. Please be

cautious when using , cleaning or maintaining the equipment and taking

proper protective measures.

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AVE-73 Urine Analyzer User's Manual

1.5 Symbols

The following is a list of symbols used on the nameplate, product packaging or

within the user manual and their corresponding meaning.

No. Symbol Description Location

1 Cautions User manual, nameplate

2 Cautions User manual, instrument

3 Warning User manual

User manual, instrument,


4 Biological hazards
nameplate

Earth terminal, the

5 terminal must be Instrument

connected firmly

6 Power on User manual, instrument

7 Power off User manual, instrument

Nameplate, product
8 Date of manufacture
packaging

In vitro diagnostic
9 Nameplate
medical device

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AVE-73 Urine Analyzer User's Manual

No. Symbol Description Location

Nameplate, product
10 Manufacturer
packaging

Consult instructions for Nameplate, product


11
use packaging

12 Fragile Product packaging

Do not use when package


13 Product packaging
damaged

14 Stacking limits Product packaging

15 Ban rolling Product packaging

16 Upward Product packaging

17 Keep dry Product packaging

1.6 Contact Information

AVE SCIENCE & TECHNOLOGY CO., LTD.

Building B6, Luguyuyuan, No.27 Wenxuan Road

Changsha Hi-tech Industrial Development Zone,

Hunan 410205, [Link]

Tel: +86-731-8892 5308

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AVE-73 Urine Analyzer User's Manual

Fax: +86-731-8890 7046

Website: [Link]

1.7 Statement

AVE Science & Technology Co., Ltd. (Hereafter called “AVE Science &

Tecnology”) reserves the final explanation to the manual. The product pictures and

product information involved in this manual are for reference only. Please refer to

the actual product in the end. The company reserves the right to modify the

manual and products, subject to change without notice

When all the following requirements are met, AVE Science & Technology

believes that it should be responsible for the safety, reliability and performance of

the product, namely:

a. The assembly operation, expansion, re-adjustment, improvement and repair

are all carried out by professionals approved by AVE Science & Technology;

b. All replaced spareparts involved in maintenance, supporting accessories and

consumables are the original ones from AVE Science & Technology or the ones

approved by AVE Science & Technology;

c. The relevant electrical equipment meets the national standards and the

requirements of this product manual;

d. The product operation is carried out in accordance with this product manual.

WARNING: This analyzer can only be operated and used by

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AVE-73 Urine Analyzer User's Manual

laboratory professionals, doctors and experimenters trained by AVE Science &

Technology or its distributors。

WARNING: If the hospitals or institutes carried the responsibility of

using analyzer don’t have a set of stasified repairmen or maintenance plan, it

may cause the unnormal analyzer failure and may endanger your health.

WARNING: Please make sure to use the analyzer under the use

conditions and protection measures required in the manual. If it is out of use

conditions and allowed risk levels, the analyzer may can’t run normally, the

testing results will not be reliable, and it may cause damage to the parts of

analyzer and endanger your health.

WARNING: If the moving parts will inevitably be exposed during

normal operation, the operator can operate the precudures only after they

have had enough trainings on the most safe way of these operating

procedures.

WARNIGN: If the instrument is not used, transported or handled, the

operator should abide by the laboratory safety operation regulations and wear

personal protective equipment (such as laboratory protective clothing , gloves,

etc.

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AVE-73 Urine Analyzer User's Manual

1.8 Warranty

AVE Science & Technology provides lifetime maintenance service for its

products sold by the authorized distributors or agents. For failures caused by

product quality problems under normal use conditions, AVE Science & Technology

will provide a 24-month warranty period, or replace them according to the

company's specific provisions on service commitments. During the 24-month

warranty period, maintenance service fees and accessory fees are waived; after the

warranty period, related expenses incurred will be charged according to relevant

standards.

In one of the following situations, you do not enjoy free warranty service:

a. Damages and failures caused by natural disasters and accidents (such as fire,

earthquake, lightning strike);

b. Failure caused by not operating as required, using in unacceptable working

environment and conditions (including unstable voltage of local power system, and

failure to select a good quality regulator, etc.);

c. Damage casued by the product repaired and its additional parts replaced

by persons not authorized by AVE Science & Technology;

d. The warranty does not include outer shell, accessories, consumables (such as

printing paper, etc.);

e. Damage caused by improper transportation after delivery (such as:

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AVE-73 Urine Analyzer User's Manual

appearance damage, components falling off due to shock);

f. Computer failures caused by deleting or moving computer content or loading

other software, etc.;

g. Failure to provide a valid warranty certificate or the content of the certificate

is inconsistent with the product or has been altered.

1.9 Limitation of Liability

The company is not responsible for any loss of use, income or expected profit,

nor is it responsible for any indirect or incidental damage caused by the sale or use

of this product.

1.10 Safety Instructions and Precautions

In order to minimize the failure of the instrument, the user is subject to the

following requirements.

a. The product instrument should be used by authorized personnel, and it is

forbidden to use it by others.

b. Establish good usage habits and do not insert mobile storage devices from

unknown sources that are not disinfected.

c. The upgrade of product software should be done by authorized

professionals.

1.11 Intellectual Property

The intellectual property rights of this product manual and its corresponding

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AVE-73 Urine Analyzer User's Manual

products belong to AVE Science & Technology.

Copyright: Without the written consent of AVE Science & Technology, no

individual or organization may copy, modify or translate any part of this manual.

Disclaimer: AVE Science & Technology has the final right to interpret this

product manual.

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AVE-73 Urine Analyzer User's Manual

2 SYSTEM INSTRUCTION

2.1 Working Principle


After placing urine test strip impregnated with urine sample on the test strip

holder as required, the transmission device of the instrument will transport urine

test strip directly under the detector, turn on the light source, and automatically

scan the reflected light of each test pad of urine test strip, which has finished

chemical reaction, by the detection device. Each test pad of urine test strip reacts

independently with the corresponding components in the urine, displaying

different colors, and the color depth is proportional to the concentration of the

components in the urine. The darker the color of each test pad after reaction, the

greater the value of absorbed light, and the smaller the value of reflected light, the

smaller the reflectivity. On the contrary, the lighter the color, the smaller the value

of absorbed light, and the greater the value of reflected light, the greater the

reflectivity. According to the principle of photoelectric colorimetry, the color

change produced by the reaction between the color pad of urine test strip and the

components in the urine is used to determine the concentration of each test items

in the urine (Bilirubin, Protein, Urobilinogen, Glucose, Ketones, Blood, Nitrite, PH,

Specific Gravity, Leukocytes, Ascorbic Acid, Creatinine, Calcium, Microalbumin,

etc.). Through software processing to determine the results of chemical test items,

and finally form a complete test report.

Urine analyzer is equipped with a blank board as a random standard to

correct the errors of the instrument's light source and sensor. The measured light

value of each test strip's reflected light is divided by the light value of the blank

board's reflected light to obtain the reflectance. The content of biochemical

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AVE-73 Urine Analyzer User's Manual
components in urine is determined based on reflectance.

The calculation formula of reflectance is as follows:

𝑇𝑇𝑚𝑚 × Cs
𝑅𝑅 = × 100%
𝑇𝑇𝑠𝑠 × Cm
In the formula:

R —— Reflectivity

𝑇𝑇𝑚𝑚 —— The reflection intensity of urine test strip measuring wavelength

Cs —— The reflection intensity of the blank board measuring wavelength

during the production of the instrument

𝑇𝑇𝑠𝑠 —— The reflection intensity of the blank board measuring wavelength

during the test

Cm —— The reflection intensity of the white standard measuring wavelength

during the production of the instrument.

2.2 Performance and Technical Indicators

2.2.1 Main Detected Parameters

Bilirubin (BIL), Protein (PRO), Urobilinogen (URO), Glucose (GLU),

Ketones(KET), Blood (BLD), Nitrite (NIT), PH, Specific Gravity (SG), Leukocytes

(LEU), Ascorbic Acid (VC), Creatinine (CRE), Calcium (Ca), Microalbumin (MCA),

etc. The specific items are determined by the matched urine test strips.

2.2.2 Main Functions

Power-on self-checking: The analyzer can self-checking after power-on, identify

faults and report error messages.

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AVE-73 Urine Analyzer User's Manual

Reporting function: Report results include the plus sign system, common unit

system and international unit system.

Data recording function: The analyzer has the function of storing and querying test

results, and the data can still be saved after power failure.

Input function: The analyzer is equipped with buttons or touch screen, and can

input relevant information with LCD display.

Printing function: The result can be output through the built-in thermal printer; it

can be displayed through the LCD.

Data transmission function: The result can be output through the network port; it

can also be uploaded to the host computer through the serial port, so as to connect

with the hospital management system or to further analyze the test results.

Software upgrade: Through USB, serial port and special software, the analyzer

software can be easily updated and upgraded.

Alarm function: With fault alarm function.

2.2.3 Perfomance Indicators

[Link] Testing Speed

Analyzer Model Test Speed

AVE-731A

AVE-731B
120 tests/hour
AVE-731C

AVE-731D

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AVE-73 Urine Analyzer User's Manual

AVE-732A
300 tests/hour
AVE-732B

AVE-733A
514 tests/hour
AVE-733B

[Link] Repeatability

The coefficient of variation (CV,%) of the reflectance test result of the analyzer

is ≤1%.

[Link] Accuracy

The difference between the test result and the label value of the corresponding

reference solution shall not exceed one order of magnitude in the same

direction, and there shall be no reverse difference, the positive reference

solution shall not have a negative result, and the negative reference solution

shall not have a positive result.

[Link] Stability

Within 8 hours of starting the analyzer, the coefficient of variation (CV, %) of

the reflectance test results is ≤ 1%.

[Link] Carryover Contamination

Test the positive sample with the highest concentration of each item except the

specific gravity and PH, and then test the negative sample. The negative sample

shall not be positive.

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AVE-73 Urine Analyzer User's Manual

2.3 System Structures


AVE-73 series urine analyzer consists of the following modules: the instrument

consists of a shell, power supply, motion transmission part, measurement part

(light source, light receiver, etc.), control calculation part (computer system), touch

screen, output (LCD Or printer) and interface part (serial port and USB port).

2.3.1 AVE-733A Urine Analyzer Host

The appearance structure picture of the instrument host is as follows:

5
4

Figure 2-1 Front View of Analyzer

1. LCD screen; 2. Printer; 3. Placement area for test strips to be inspected; 4.

Indicator light; 5. Waste box;

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AVE-73 Urine Analyzer User's Manual

1 2 3 4 5

Figure 2-2 Back View of Analyzer

1. USB Port; 2. Data Communication Port 1; 3. Data Communication Port 2;


4. Power Port; 5. Power Switch;

2.3.2 Data Analysis Processor

The data analysis processor is a system that provides a user interface,

completes data calculations, and outputs statistical analysis reports. The functional

block diagram of the data analysis processor is as follows:

15
AVE-73 Urine Analyzer User's Manual

2.4 Software Function and Composition

This analysis and processing software can realize semi-quantitative analysis

and detection of chemical components in urine. The analysis and processing

software has the following functions:

• Semi-automatic test function: detect whether the user puts the test strips,

and automatically move it under the scanner head inside the machine for testing;

• Historical data query function: conditional filtering and editing of historical

test data;

• Data entry and query function: bind relevant patient information, edit and

view patient information;

• Report printing function: automatic real-time printing or preferred printing

of the detected data;

• Parameter setting and software update and upgrade.

After the startup process is over, the instrument automatically enters the main

menu interface.

16
AVE-73 Urine Analyzer User's Manual

Figure 2-3 Main Menu Interface

The main menu interface has the following three menus:

• Test: Including sample testing and quality control testing

• Inquery: Include sample inquery and quality control inquery

•Setting: Including instrument settings, quality control settings, report settings,

calibration settings, maintenance

The status bar is divided into three parts from left to right: the first part is the

current status prompt area of the system, that is, the area occupied by "standby" in

the figure; the second part is the status icon indicator area, which is used to indicate

the current status of the system, like select the test strip type, external device status,

network connection status, etc., which is the area occupied by " " in the figure;

the third part is the system date and time display area.

17
AVE-73 Urine Analyzer User's Manual

The bottom left of the interface is the shutdown button. The user clicks the

shutdown button and the system pops up the following prompt message:

Figure 2-4 Shutdown Interface

The user clicks the confirmation key "√", the system enters the shutdown state;

clicks the cancel key "×" to return to the main menu interface.

2.4.1 Test Menu

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AVE-73 Urine Analyzer User's Manual

Figure 2-5 Test Menu Interface

The test menu includes the following functional operation submenus:

Name Function Remarks

Enter the sample test interface to perform


Sample Test None
routine tests on patient urine samples

Enter the quality control testing interface, use


Quality
the quality control liquid to perform quality None
Control Test
control tests on the instrument

2.4.2 Inquiry Menu

Figure 2-6 Inquiry Menu Interface

The inquery menu includes the following functional operation submenus:

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AVE-73 Urine Analyzer User's Manual

Name Function Remarks

Sample Enter the condition screening interface for


None
Inquiry conditional query of historical sample data

Enter the condition screening interface for


QC Inquiry None
conditional query of historical quality control data

2.4.3 Setting Menu

Figure 2-7 Setting Menu Interface

The setting menu includes the following functional operation submenus:

Name Function Remarks

Can enter the instrument's communication


Analyzer
parameters, language, date and time, screen backlight None
Setting
brightness and test strip type

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AVE-73 Urine Analyzer User's Manual

Quality
Can enter the quality control liquid batch and its brand
Control None
and cut-off value table
Setting

Report Can set and preview the report transmission and


None
Setting printing method, data unit

Calibration Can calibrate each dry chemical test items Authorized

Setting independently (password required) Engineer

Maintain Can adjust and set parameters of internal detection Authorized

Setting components of the instrument (password required) Engineer

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AVE-73 Urine Analyzer User's Manual

3 INSTALLATION

3.1 Summary

Anyone who is not trained by AVE or authorized distributors of AVE may cause

damage to the analyzer when opening the box or installing the instrument.

Therefore do not open the box or install the instrument without an authorized

technician being present.

On receiving the analyzer, please check the package carefully to see whether

there is a physical damage. If there is any, please notify your local distributor

immediately.

3.2 Installation Requirements

3.2.1 Space

The AVE-73 series main unit size is 380×320×190mm and main unit weight is

4.5kg. Instrument is requiring enough free space on a countertop.

3.2.2 Power

Model
Voltage Frequency Input power Fuse

AVE-731A
AVE-731B
≤35VA
AVE-731C
AVE-731D T3.15A 250V
~220V 50Hz
AVE-732A Φ5×20
AVE-732B
≤45VA
AVE-733A
AVE-733B

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AVE-73 Urine Analyzer User's Manual

CAUTION: UPS no less than 1000VA or voltage regulator are

recommended to maintain system operation if voltage is not stable or power

outage is regular.

CAUTION: The equipment inside fixed covered areas of the instrument are

not user serviceable and may present electrical shock hazards.

WARNING:For continued protection against risk of fire and hazard,

replace only with the same type and rating fuse.

WARNING:Equipment requires connection to protective earth for safety

reasons.

WARNING:The instrument’s main supply inlet is being used as the mains

disconnect device.

3.2.3 Environmental requirements

The instrument is suggested to be installed in the environment as:

a)Power supply rating: ~220V, 50Hz, 45VA, with a good grounding

environment;

b)Normal working temperature:5℃~40℃;

c)Relative humidity:30%~80%;

d)Atmospheric pressure:76kPa~106kPa;

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AVE-73 Urine Analyzer User's Manual

e)The instrument should be placed on a fixed and stable countertop,The rear

of the host is required to be no less than 20cm from obstacles such as walls;

There should be no obstacles on the left side of the instrument that hinder the

normal use of the power switch.

f)Do not get close to strong electromagnetic source as not to affect the normal

operation of equipment;

g)Avoid direct sunlight or exposure to heat or wind.;

h)Keep it free from mechanical vibration, noise and power interruptions.;

i) The power jack should comply with electrician specifications and must have a

reliable grounding wire;

j)UPS no less than 1000VA or voltage regulator are recommended to maintain

system operation if voltage is not stable or power outage is regular.

Environmental conditions for transportation and storage

a)Normal temperature range:0℃~50℃;

b)Relative humidity range:10%~95%;

c)Atmospheric pressure range:76kPa ~106kPa。

3.2.4 Installation requirement

The AVE-73 series has to be installed by an authorized technician.

3.3 Packing list

The list of accessories and consumables used with this instrument are as follows:

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AVE-73 Urine Analyzer User's Manual

Items Unit Quantity Usage Note

Printer paper Roll 1 Assorts parts

Test strip Box 1 Assorts parts

Host power cord pcs 1 Assorts parts

Fuse(T3.15A Φ5×20) pcs 2 Backup parts

The assorts parts are the necessary parts for the normal use of the

instrument,This material will be removed from the instrument during

transportation and packaged [Link] are the materials that need

to be consumed during normal use of the instrument,the test strips are disposable

consumables,the backup parts was used as wearing parts of the instrument,for the

replacement cycle and method, please refer to Chapter 8 Maintenance and Service.

3.4 Load Paper into Printer

a)Click the printer cover release button, open the printer cover carefully and

remove the rubber paper roller (see Figure 3-1).

Figure 3-1 Open the printer cover

b)Take out the paper roll,remove the wrap. Insert the paper roll into the paper roll
25
AVE-73 Urine Analyzer User's Manual

holder. Insert the start of the paper roll under the rubber paper roller. Position the

paper appropriately,(see Figure 3-2).

Figure 3-2 Insert the paper roll

c)Feed the extra paper outside of the paper roller through the slot on the cover.

Close the printer cover. (see Figure 3-3).

Figure 3-3 Close printer cover

Thermal paper roll must be installed and fed appropriately, otherwise

crooked printing or paperjam may occur.

3.5 Power cord connection

Connect one end of the host power cord that is randomly configured to the

power input interface on the back of the instrument host, and plug the other end

into the dedicated wiring board for the [Link] ensure safety, please note

that before connecting the power cord of the instrument, place the power switch of

the instrument in the "O" position, ensure the instrument is turned off and power

strip is also power-off.

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AVE-73 Urine Analyzer User's Manual

4 SETTINGS

When using this instrument for the first time, some parameters can set

according to the needs of the users.

CAUTION: The chapter is for “Administrator” only.

CAUTION:Changing of the factory parameter settings could affect the

normal use of the instrument , if it’s necessary, please read the user’s manual first

or contact manufacture.

After the start-up process is over, the instrument automatically enters the main

menu interface, select settings, and enter the settings menu interface.

Figure 4-1 Settings menu

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AVE-73 Urine Analyzer User's Manual

4.1 Instrument settings

4.1.1 Parameter settings

The user can set the serial port parameters, test paper type, system date and

time, system language, and screen [Link] serial communication

parameters include: baud rate, stop bit, data bit, parity bit. See Figure 4-2.

Figure 4-2 Instrument setting interface

The user selects the type of parameter to be modified, and clicks on the right

end of the parameter“ ”,Select the parameter to be set in the pop-up menu, and

click to select the [Link] setting,click“ ”to save,instrument pops up

(Figure 4-3 Parameter save prompt window) whether to save the current

configuration window,Click“ ”to save.

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AVE-73 Urine Analyzer User's Manual

Figure 4-3 Parameter saving window

The instrument supports a variety of urine test strips. Please confirm

whether the actual test strip used is consistent with the test strip selected

under the "Settings>Instrument Settings>Test Paper Type" menu, otherwise it

will cause incorrect test results.

4.1.2 Factory information

Select in Figure 4-2 in the instrument setting interface' 'icon,The system

will display Figure 4-4 Factory Information [Link] view the factory

information of the instrument.

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AVE-73 Urine Analyzer User's Manual

Figure 4-4 factory information

4.1.3 Software upgrade

To upgrade the program software, users need to have the latest program

files,and click the window button in Figure 4-4“ ”icon, wait for the system

upgrade to complete.

Software upgrades must be performed by authorized engineers.

4.2 Quality control settings

In the quality control setting interface (Figure 4-5 Quality control setting interface),

users can add or delete quality control information, select historical quality control

batch numbers from the drop-down list in the quality control batch number combo

box, and modify brand and threshold value.

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AVE-73 Urine Analyzer User's Manual

Figure 4-5 Quality control setting interface

Add quality control batch number, select quality control brand, enter the

new batch number in the quality control batch number combo box and click [Link]

shown in Figure 4-6, add quality control batch number interface, for the edit box

corresponding to each item, click to modify its value, select the correct standard

value, and then modify its low value and high value,click“ ”to save quality

control information.

Delete quality control batch number, select the corresponding quality

control batch number, and click the delete button to delete the quality control

information.

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AVE-73 Urine Analyzer User's Manual

Figure 4-6 Add quality control lot number interface

4.3 Report setting

The report setting interface can set the sample printing and [Link]

setting, Click“ ”to save.

Real-time printing: The option can control whether to perform real-time printing

during testing.

External printing: If the instrument connected to a printer, user can select whether

to use an external printer for report printing.

Bluetooth transmission:Control whether report data is transmitted to the remote

end via Bluetooth

Network transmission:Control whether report data is transmitted to the remote

end through the network.

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Data unit: Select the unit of data display in the report.

Real-time printing and external printing cannot be selected at the same time.

Figure 4-7 Report setting interface

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5 SAMPLE PROCESSING

5.1 Power on

In order to ensure that the instrument keeps in good working condition, it is

recommended to start your computer as follows:

1 Turn on the UPS (if available);

2 Turn on the power distribution board (if available);

3 Place the power switch on“ ”;

5.2 Sample Preparation

Only use fresh urine sample.

Collect urine sample into clean container. If the urine specimen do not

detected in 1h, it need to store at 2-8℃ and restore to room temperature before

testing.

Caution:Fully mixed before testing.

Caution:Do not add disinfectant or detergent to the sample.

Caution:Avoid direct sunlight on the sample.

Caution:Do not centrifuge the urine sample.

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AVE-73 Urine Analyzer User's Manual

5.2.1 Ambient temperature requirements

The urine sample is detected at room temperature. If it store at 2-8℃, it need to

restore to room temperature before testing.

Biological hazards:Urine samples, quality control liquid and waste

liquid are potentially at risk of biological infection. The user should follow the

laboratory safety rules and wear personal protective equipment when touch

the medical relevant stores.

5.3 Urine chemistry strips preparation

The urine chemistry strips only use the special urine strips produced by AVE

science and technology company.

Please refer to the related contents of the AVE series ”Instructions for Use of

Urine Chemistry strip”, Please follow the procedures to place the strip in the

instrument before testing:

Step 1: Please carefully check the seal of the test strip drum, before

unpacked. If the test paper drum has leaked, we do not use it that avoid the failure

strip resulting in the inaccurate test results.

Step 2: Please carefully check the shelf life on the test strip bucket, if it is over

the shelf life, we do not use it that avoid the failure strip resulting in the inaccurate

test results.

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AVE-73 Urine Analyzer User's Manual

Caution:The urine chemistry strips only use the special matched urine strips

produced by our company. Otherwise, the normal operation of the instrument and

the accuracy of results can hardily be guaranteed.

5.4 Sample test

The program interface is shown in Figure 5-1, choose “test”>”sample

test”(Figure 5-2) in program interface of urine chemistry analysis.

Figure 5-1 Program interface

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AVE-73 Urine Analyzer User's Manual

Figure 5-2 Testing interface

Figure 5-3 Sample test interface

In the sample test interface, the first line of urine chemistry parameter is used

to show the meaning of each column of data. A single page can show up to 6 lines

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AVE-73 Urine Analyzer User's Manual

of results. If there are too many results, it will be displayed in pages. This program

acquiescently displays all the tested result data of the day. On the status line, the

words displayed on the right of the panel represents "current page/total page

number", and the rest are function keys. The description of each function key is

shown in the following table:

Button Icon Function Notes

The retest item will be displayed at the

top of the table, the sample number


Reselect the sample
marked with "*" will be displayed
number
immediately above the retest item after

the data result obtained.

Back to the home page None

Back to the previous page None

Back to the next page None

Back to the last page None

Delete the selected result The user needs to confirm it after click

Print the selected result The user needs to confirm it after click

Upload the selected result The user needs to confirm it after click

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AVE-73 Urine Analyzer User's Manual

Take a strip into the urine sample tube, and take it out quickly after it is fully

wet. At the same time, scrape the edge of the test tube to avoid taking out too

much urine, and then suck out the excess urine on the paper. Place the strip on the

tray as shown in Figure 5-4. After the strip move, the instrument has accept the

photoelectric signals of the strip, and automatically detect the sample.

Figure 5-4 Place strip

The reagent area of the strip must face up.

Each strip must be placed vertically between the first column of bulge carriers

and the second column of bulge carriers on the feed table.

The far tip (the tip that is not in hand) must exceed the top of the bulge

carriers.

When the operator is placing the strip, strip detector detects the motion and

carries the strip into the analyzer. As shown in Figure 5-5, the number queue of test

strips on the tray is displayed on the top of the screen in real time. The number

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AVE-73 Urine Analyzer User's Manual

0013 will be displayed in the first line of the table, which is used to represent the

samples currently being tested. Consequently, the prompt area will show the

movement position of the test paper in real time. The blue circle ring represents the

test paper that has been detected on the machine. As the test paper moves forward

in the machine, the blue circle ring will move forward one by one during the test

until test finished. The figure ‘ ’ represents that the last on-machine test

strip number is 0013.

Figure 5-5 Sample test interface

After the strip is inside the analyzer, there is another confirmation sensor to

confirm there is a new strip in queue. Only after being detected by the confirmation

sensor, the strip will be moved to testing position and start the test, and

consequently the indicator light will be blue and the buzzer will beep. Operator can

immediately start the next cycle of strip dipping and drying. After the previous strip

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AVE-73 Urine Analyzer User's Manual

is being transferred to the right and a new strip position is available on the feed

table, operator can place the next prepared strip, and so on. Spaces (skips) are

allowed between two strips. That would not affect sample numbers. Samples (strips)

are numbered according to actually detected strips, instead of steps made by the

motor.

After the test finished, the results are also saved into the FLASH ROM inside the

analyzer. No data is lost if power is out. Saved testing reports can be viewed any

time.

5.5 Quality Control

The quality control program is a tool used to evaluate the accuracy and

stability of the instrument. Through the statistical analysis of the quality control

data, the accuracy and stability of the instrument can be effectively monitored.

5.5.1 Control Frequency

Controls should be run at least once every 24 hours or as specified in the

Laboratory’s QC Procedure.

5.5.2 QC Parameters Input

See Chapter 4 section 4.2 Quality Control settings, and enter to the

corresponding quality control parameter input interface.

5.5.3 Running QC

After the quality control parameters are entered, in the test interface, the QC

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AVE-73 Urine Analyzer User's Manual

can be run according to the following steps:

Click the “Test”button in the main screen.

Click “QC test” button;

Select the Lot number for the QC in the pop-up dialog box, and click OK;

Refer to the sample test method to test the quality control solution.

5.5.4 QC result

[Link] QC test result

After the quality control measurement is completed, the test results can be

displayed in the quality control test interface, as shown in Figure 5-6.

Figure 5-6 QC test result screen

[Link] QC Inquiry

Click the “ ” button on the main screen, enter to the inquiry screen, Click

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AVE-73 Urine Analyzer User's Manual

the QC inquiry button " " in the inquiry screen to enter the QC inquiry, as

shown in Figure 5-7, enter Lot number and date in the inquiry screen and click

the button " ", the system will show the QC inquiry results as shown in

Figure 5-8.

Figure 5-7 QC inquiry screen

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AVE-73 Urine Analyzer User's Manual

Figure 5-8 QC inquiry results screen

5.5.5 Remedies on Out-of-control

Influencing factors and solutions for out-of-control QC results:

NO. Possible Reasons Solutions

1 QC material is not mixed Make sure the sample is well


sufficiently mixed, then do the QC test
again.

2 QC material expired or invalid Change the QC material and do


the QC test again.

3 Test strips expired or invalid Change the new LOT strips and
do the QC test again.

If the problem of QC out-of-control cannot be solved, please contact

authorized service personnel.

5.6 Data inquiry

5.6.1 Patient data entry

Select the test record and long presses it in the test screen (as shown in Figure

5-5), and the patient data entry screen will pop up, as shown in Figure 5-9. The

user can enter and modify the patient data for the corresponding specimen.

After entering the information, click the " " button to save it.

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AVE-73 Urine Analyzer User's Manual

Fig 5-9 Patient data entry screen

5.6.2 Print report

Select the test record in the test screen(as shown in Figure 5-5), click the print

button " " in the function key area to print the currently selected sample.

5.6.3 Data inquiry

Click the " " button in the main screen (Figure 5-1), and the system will enter

the inquiry screen as shown in Figure 5-10. Select the sample inquiry, then there

will pop up the inquiry condition selection screen, after selecting the specified

conditions as needed, click the inquiry button " ", and the inquiry results

screen will pop up as shown in Figure 5-12. In this screen, the user can delete,

print and transfer the results for the samples.

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AVE-73 Urine Analyzer User's Manual

Figure 5-10 Inquiry screen

Figure 5-11 Condition inquiry screen

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AVE-73 Urine Analyzer User's Manual

Figure 5-12 Sample Inquiry Results Screen

5.7 Power off

After all the Samples have been tested, Please follow the steps below:

1. Click the " " button on the sample test screen, the system will pop up a

dialog box whether to quit the test screen ( as shown in Figure 5-13), click "

" button to quit the test screen;

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AVE-73 Urine Analyzer User's Manual

Figure 5-13 Quit test screen

2. Click the " " button on the sample test screen again, back to main

screen.

3. Click the“ ”button on the main screen, the system will pop up a dialog

box whether to turn off the analyzer ( as shown in Fig 5-14), click " "

button to turn off the analyzer.

Fig 5-14 turn off the analyzer screen

4. when the system is shut down, please turn off the power switch of the

analyzer.

Caution: Discarded test strips have a certain potential biological

contamination risk. After finished the sample testing on the day, must be disposed

of in time according to local or laboratory regulations.

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AVE-73 Urine Analyzer User's Manual

Caution:Turn off the power switch of the instrument after confirming that the

system is shut down to avoid data loss caused by abnormal power failure.

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AVE-73 Urine Analyzer User's Manual

6 MAINTENANCE AND SERVICE

6.1 Maintenance

6.1.1 Precautions

CAUTION: Improper maintenance may damage the analyzer. The operator

should follow the instructions of the user manual for maintenance.

CAUTION: If you encounter a problem that is not clear in the user manual,

please contact AVE for customer support.

CAUTION: The analyzer must be maintained with spare parts provided by

AVE. If you have any questions, please contact AVE for customer support.

WARNING: Samples, waste strips, etc. are potentially biologically

infectious. Operators should follow the laboratory safety operation regulations

and wear personal protective equipment (such as protective clothing, gloves,

etc.) when touching related objects in the laboratory. Dispose the contaminants

in accordance with applicable regulations.

6.1.2 Daily Maintenance

Items Suggested Intervals

Cleaning instrument surface Daily

Cleaning waste strip box Daily

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AVE-73 Urine Analyzer User's Manual

6.1.3 Periodic Maintenance

Items Suggested Intervals

Cleaning strip tray Weekly

Changing the fuse As Needed

Cleaning Photoelectric Sensors As Needed

6.2 Daily Maintenance

This procedure should be performed at least once daily.

6.2.1 Cleaning Instrument Surface

Items needed: Disinfectant/cleanser, gauze, and protective gloves.

Procedure: Power off the instrument. Clean the instrument using gauze

moistened in disinfectant/cleanser. Wipe again using distilled water and then

make it dry.

CAUTION: Immediately power off the analyzer and clean it when

samples are pouring into the analyzer.

6.2.2 Cleaning Waste Strip Box

WARNING: Waste strips and waste strip box are potentially biologically

infectious. Operators should follow the laboratory safety operation regulations

and wear personal protective equipment (such as protective clothing, gloves,

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AVE-73 Urine Analyzer User's Manual

etc.) when touching related objects in the laboratory.

It is recommended to clean the waste box strip daily. After testing all samples,

dispose the waste test strips in time according to the laboratory procedures and

clean the waste box. Cleaning method is as following:

Items needed: Disinfectant (such as glutaraldehyde, peracetic acid, hydrogen

peroxide, chlorine dioxide, etc.), distilled water, gauze, protective gloves.

1. Turn off the analyzer, pull out the waste box, as shown in Figure 6-1, and

discard the waste strips inside;

Figure 6-1 Take out the waste box

2. Wipe the waste box with gauze dipped in disinfectant, and remove any

deposits.

3. Wipe it again with gauze dipped in distilled water.

After the box is completely dry, plug it back into the analyzer. Use uniform

force, the guide rail on the box should be aligned with the guide groove on the

shell, and push it until the waste box is flat with the shell.

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AVE-73 Urine Analyzer User's Manual

6.3 Weekly Maintenance

6.3.1 Cleaning strip tray

If sample leaks onto the tray, please clean it in time to avoid affecting the

normal use of the analyzer.

CAUTION: The tray is an important part of the analyzer and must be

properly maintained. Do not use detergent or hot water, DO NOT bake or heat

it. Once deformed, it will directly affect the test results.

Items Needed: disinfectant/cleaner, cotton swabs, gauze, protective gloves, etc.

Maintenance steps:

1. Power off the instrument, make sure the operation is in shutdown state.

2. Pull out the tray as shown in Figure 6-2;

Figure 6-2 Take out the tray

3. Wipe the tray with gauze dipped in disinfectant, and remove any deposits.

4. Wipe it again with gauze dipped in distilled water.

After the tray is completely dry, insert it back into the tray slot. Use uniform

force and don't push too hard. Don't push hard when encountering resistance.

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AVE-73 Urine Analyzer User's Manual

Retreat and push in until the tray is in place.

6.4 As Needed Maintenance

6.4.1 Cleaning Photoelectric Sensors

Items Needed: 95% absolute alcohol, cotton swabs and protective gloves

Procedure:

1 Power off the instrument, make sure the operation is in shutdown state.
2 Using a cotton swab moistened with absolute alcohol to swab the surface of
photoelectric sensors
3 Swabs dry them by using a dry cotton swab.

6.4.2 Changing the Fuse

When the analyzer's fuse is burned out and the analyzer cannot be powered

normally, the fuse can be replaced as follows:

CAUTION: Be careful of electric shock! Make sure to power off and

unplug the power cord first. When replacing, make sure to use the same

specification one.

CAUTION: Please replace by professionals!

1 Turn off the power switch;

2 Unplug the power cord on the back;

3 Remove the fuse box from the power socket with screw driver;

4 Take out the broken fuse;

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AVE-73 Urine Analyzer User's Manual

5 Replace the fuse of the same specification;

6 Put the fuse box into the power socket;

7 Connect the power cord again.

6.5 Troubleshooting

Operating and maintaining the analyzer acording to the user manual will generally

enable the analyzer to work normally. When the analyzer detects an abnormal

situation, it will display an error message, it will help the operator to solve the

problem or contact the seller or manufacturer for help according to the prompt.

The following is the error messages list, shows the error content and solutions.

No. Error description Error solution

The analyzer shows "conveyor 1. Turn off the analyzer and then restart;

1 point failure" 2. If the error still exists, please contact

authorized engineer.

The analyzer shows "Strip 1. Turn off the analyzer and then restart;

2 detection sensor failure" 2. If the error still exists, please contact

authorized engineer.

The analyzer shows "Scan head 1. Turn off the analyzer and then restart;

3 motor failure" 2. If the error still exists, please contact

authorized engineer.

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No. Error description Error solution

The analyzer shows "Scan head 1. Turn off the analyzer and then restart;

4 communication timeout" 2. If the error still exists, please contact

authorized engineer.

The analyzer shows "Scan head 1. Turn off the analyzer and then restart;

5 LED failure" 2. If the error still exists, please contact

authorized engineer.

The analyzer shows "Scan head 1. Turn off the analyzer and then restart;

6 didn't scan the correct strip" 2. If the error still exists, please contact

authorized engineer.

The analyzer shows "Waste 1. Check whether the waste strip box is

strip box full" full, if it is full, empty it, and click the "OK"

7 button;

2. If the error still exists, please contact

authorized engineer.

The analyzer shows "Waste strip 1. Put the waste strip box back in place;

box not installed" 2. If the error still exists, please contact


8
authorized engineer.

The analyzer shows "Strip tray 1. Put the strip tray back in place;
9
not installed" 2. If the error still exists, please contact

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No. Error description Error solution

authorized engineer.

The analyzer shows "Strip is 1. Check whether the strip is placed upside

upside down" down;

10 2. Turn off the analyzer and then restart;

3. If the error still exists, please contact

authorized engineer.

The analyzer shows "Strip is 1. Check whether the strip is placed skewly

skew" and crosses the push teeth;

11 2. Turn off the analyzer and then restart;

3. If the error still exists, please contact

authorized engineer.

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